Active Ingredient
Chlorhexidine gluconate 4% solution
Betasept Solution
FDA Label NDC 0116-0200
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Xttrium Laboratories, Inc. for the product Betasept (NDC 0116-0200). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Uses
- surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care
- healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
- patient preoperative skin preparation: preparation of the patient's skin prior to surgery
- skin wound and general skin cleansing
Warnings
Warnings
For external use only
Allergy alert:
This product may cause a severe allergic reaction. Symptoms may include:
- wheezing/difficulty breathing
- shock
- facial swelling
- hives
- rash
If an allergic reaction, stop use and seek medical help right away.
Do Not Use
- if you or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product
- in contact with meninges
- in the genital area
- as a preoperative skin preparation of the head or face
When Using This Product
- keep out of the eyes, ears, and mouth. May cause serious and permanent eye injury if placed or kept in the eye during surgical procedures or may cause deafness when instilled in the middle ear through perforated eardrums.
- if solution should contact these areas, rinse out promptly and thoroughly with water
- wounds which involve more than the superficial layers of the skin should not be routinely treated
- repeated general skin cleansing of large body areas should not be done except when advised by a health care provider
Stop Use And Ask A Doctor If
irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
- wet hands and forearms with water
- scrub for 3 minutes with about 5 mL of product and a wet brush, paying close attention to the nails, cuticles, and interdigital spaces
- a seperate nail cleaner may be used
- rinse thoroughly
- wash for an additional 3 minutes with 5 mL of product and rinse under running water
- dry thoroughly
- wet hands with water
- dispense about 5 mL of priduct into cupped hands and wash in a vigorous manner for 15 seconds
- rinse and dry thoroughly
- apply product liberally to surgical site and swab for at least 2 minutes and dry with a sterile towel
- repeat procedure for an additional 2 minutes and dry with a sterile towel
- thoroughly rinse the area to be cleaned with water
- apply the minimum amount of product necessary to cover the skin or wound area and wash gently
- rinse again thoroughly
Surgical hand scrub
Healthcare personnel handwash
Patient preoperative skin preparation
Skin wound and general skin cleansing
Other Information
store at 20-25°C (68-77°F)
avoid excessive heat above 40°C (104°F)
Inactive Ingredients
cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol
Questions Or Comments?
call 1-888-827-0624 (8am-5pm, EST, Mon-Fri)
Other Safety Information
WARNING: Cancer - www.P65Warnings.ca.gov
Package Label.Principal Display Panel
NDC 67618-200-04
From the Makers of BETADINE® products
For External Use Only
Not for Retail Sale
For Professional and Hospital Use Only
Single Use
BETASEPT®
Antiseptic Non-Sterile Surgical Scrub
Chlorhexidine Gluconate 4%
Net Contents: 4 fl oz (118 mL)
Dist. by: Avrio Health L.P. Stamford, CT 06901-3431
4BET04BTLLBLG
NDC 67618-200-08
From the Makers of BETADINE® products
For External Use Only
Not for Retail Sale
For Professional and Hospital Use Only
BETASEPT®
Antiseptic Surgical Scrub
Chlorhexidine Gluconate 4%
Net Contents: 8 fl oz (237 mL)
Dist. by: Avrio Health L.P. Stamford, CT 06901-3431
4BET08BTLLBLG
NDC 67618-200-16
From the Makers of BETADINE® products
For External Use Only
Not for Retail Sale
For Professional and Hospital Use Only
BETASEPT®
Antiseptic Surgical Scrub
Chlorhexidine Gluconate 4%
Net Contents: 16 fl oz (473 mL)
Dist. by: Avrio Health L.P. Stamford, CT 06901-3431
4BET16BTLLBLB
NDC 67618-200-30
From the Makers of BETADINE® products
For External Use Only
Not for Retail Sale
For Professional and Hospital Use Only
BETASEPT®
Antiseptic Surgical Scrub
Chlorhexidine Gluconate 4%
Net Contents: 32 fl oz (946 mL)
Dist. by: Avrio Health L.P. Stamford, CT 06901-3431
4BET32BTLLBLB
Bet32 (Bet32)
NDC 67618-200-32
From the Makers of BETADINE® products
For External Use Only
Not for Retail Sale
For Professional and Hospital Use Only
BETASEPT®
Antiseptic Surgical Scrub
Chlorhexidine Gluconate 4%
Net Contents: 32 fl oz (946 mL)
Dist. by: Avrio Health L.P. Stamford, CT 06901-3431
4BET32PBTLLBLB
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